Clearance Summary
TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) received FDA 510(k) clearance under submission number K014120, sponsored by Diagnostics Biochem Canada, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2002-02-08.
- Submission: K014120
- Applicant / Sponsor: Diagnostics Biochem Canada, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1680
- Decision date: 2002-02-08
Classification & Regulation
This clearance is catalogued under FDA product code CDZ and 21 CFR 862.1680, within the Clinical Chemistry review panel as a Class I device.